Effects of a 24-week natalizumab treatment interruption on quality of life, fatigue, and cognition: Results from the restore study

Objective: Evaluate quality of life (QOL), fatigue, and cognition during a natalizumab treatment interruption in multiple sclerosis (MS) patients switched to placebo or alternative immunomodulatory therapy (AIT): intramuscular interferon beta‐1a (IFNbeta‐1a), glatiramer acetate (GA), or methylprednisolone (MP). Background Natalizumab reduces relapses and disability progression in MS and has beneficial effects on QOL, fatigue, and cognition. Some physicians may interrupt natalizumab therapy to reduce the risk of progressive multifocal leukoencephalopathy. Clinical and radiologic disease activity has been shown to return after 2 to 4 months following treatment interruption, but effects on QOL, fatigue, and cognition have not been documented. Design/Methods: RESTORE is a randomized, partially placebo‐controlled study to evaluate the effect of a 24‐week interruption in natalizumab treatment on MS disease activity. Enrolled patients received natalizumab for at least the preceding 12 months without relapse and had no gadolinium‐enhancing lesions on screening brain MRI. Patients were randomized 1:1:2 to continue natalizumab, or to switch to placebo or open‐label AIT. Results: Across the treatment arms, mean VAS and MFIS scores generally remained stable throughout the randomized period. Mean SDMT scores increased in the majority of patients, likely due to the expected learning effect. To evaluate long‐term and relapse effects, we will present VAS, MFIS, and SDMT scores from the randomized period and the follow‐up period. Conclusions: During a 24‐week treatment period with continued natalizumab, placebo, or AIT, measures of QOL, fatigue, and cognition remained stable.